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  5. Transcript | What does the FDA do after drugs are approved?
  1. Information for Consumers and Patients | Drugs

Transcript | What does the FDA do after drugs are approved?

Learn how we use science and data to ensure their safety, quality and efficacy

When you fill a prescription from your doctor, you trust that it will be safe and effective. That trust comes from knowing that teams of doctors, biologists, chemists, pharmacists, and other health scientists at the FDA made informed decisions about which drugs to approve, based on science and data.

But what happens after drugs are approved? HOW does the FDA continue to monitor them for years to come, and WHY is this so important? 

The FDA conducts a thorough analysis to ensure that prescription drugs are ONLY approved  after three phases of clinical trials have shown they are high-quality, safe, and work as they should. These trials can involve hundreds, or sometimes thousands, of people. 

But once the drug is on the market and available to patients for use, new data about safety and effectiveness can come to light. The FDA keeps track of that new data, which can come from patients, drug makers, or health care professionals, and may include information about negative reactions to prescriptions. 

Based on this information, the FDA may recommend that the drug maker update the drug labeling by adding warnings or updated dosage information. Changes could also include the FDA requesting a drug recall, but the need for that is rare. 

The FDA also conducts ongoing inspections of facilities where drugs are made to make sure that drug companies are following quality and safety standards.

The FDA keeps track of all this drug data and makes sure the public stays informed. You can find information about drug recalls through your health care providers and other trusted sources of health information, such as FDA’s MedWatch page, where patients can also report safety concerns.

All of these safety measures—including requesting recalls from companies—are a sign that the FDA is doing its job. By closely monitoring drugs in development, at approval, and years after, the FDA looks out for you, by ensuring that the medicines you rely on are safe and effective.

Questions about the FDA? Find the answers at www.fda.gov/drugs.

Related information

Overview of our role regulating and approving drugs | Video series

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